Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke
Author:
Xu Jie12, Wang Anxin12, Meng Xia12, Yalkun Gulbahram12, Xu Anding3ORCID, Gao Zhiqiang4ORCID, Chen Huisheng5ORCID, Ji Yong6, Xu Jun7, Geng Deqin8, Zhu Runxiu9, Liu Bo10, Dong Aiqin11, Mu Hua12, Lu Zhihong12, Li Shuya12ORCID, Zheng Huaguang12, Chen Xia12, Wang Yilong12ORCID, Zhao Xingquan12ORCID, Wang Yongjun1ORCID, Wang Yongjun, Xu Anding, Zhao Xingquan, Chen Xia, Wang Yongjun, Meng Xia, Wang Yilong, Xu Jie, Wang Anxin, Zheng Huaguang, Gao Zhiqiang, Duan Lei, Zhang Jinghua, Li Shuya, Lou Donghua, Gao Zhiqiang, Chen Huisheng, Ji Yong, Xu Jun, Geng Deqin, Zhu Runxiu, Liu Bo, Dong Aiqin, Liang Qingcheng, Yang Hong, Guo Cunju, Li Xin, He Mingli, Tian Xiangyang, Cui Yong, Zhou Junshan, Wang Ning, Wang Lei, Zhang Xinjiang, Gao Xiaoping, Lu Liping, Li Tong, Cheng Yan, Liu Kaixiang, Xi Xiaokun, Wang Baojun, Sun Lin, Zhao Shigang, Chu Xiaofan, Lian Yajun, Yan Fuling, Wang Xiaoshan, Wang Dong, Shao Bei, Jiao Jinsong, Wu Heng, Li Guanglai, Guo Libin, Wang Yongjun, Pan Suyue, Xu Anding, Li Heng, Zhuang Jianhua, Li Xin, Wu Jun, Wang Anxin, Lou Donghua, Zuo Yingting, Zhang Yijun, Zhang Xiaoli, Feng Xiaofei, Meng Xia, Wang David, Dong Kehui, Liu Yanfang, Li Hao, Chen Dawei, Lv Qiushi
Affiliation:
1. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang). 2. China National Clinical Research Center for Neurological Diseases, Beijing (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang). 3. Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Guangzhou, China (A.X.). 4. Department of Neurology, The Second Affiliated Hospital of Nanjing Medical University, China (Z.G.). 5. Department of Neurology, The General Hospital of Shenyang Military, China (H.C.). 6. Department of Neurology, Tianjin Huanhu Hospital, China (Y.J.). 7. Department of Neurology, Subei People’s Hospital of Jiangsu Province, Yangzhou, China (Jun Xu). 8. Department of Neurology, The Affiliated Hospital of Xuzhou Medical University, China (D.G.). 9. Department of Neurology, Inner Mongolia Autonomous Region People’s Hospital, Hohhot, China (R.Z.). 10. Department of Neurology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, China (B.L.). 11. Department of Neurology, Cangzhou Central Hospital, China (A.D.). 12. State Key Laboratory of Translational Medicine and Innovative Drug Development, Nanjing, China (H.M., Z.L.).
Abstract
Background and Purpose:
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS).
Methods:
A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization.
Results:
One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12–1.81];
P
=0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49–3.43 versus 1.14, 0.85–1.52).
Conclusions:
When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients.
Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT02430350.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)
Cited by
69 articles.
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